A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy (ARDA)

  • STATUS
    Recruiting
  • End date
    Feb 15, 2024
  • participants needed
    48
  • sponsor
    argenx
Updated on 27 May 2022

Summary

This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin).

Details
Condition Multifocal Motor Neuropathy
Treatment Placebo, ARGX-117
Clinical Study IdentifierNCT05225675
Sponsorargenx
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Capable of giving signed informed consent form (ICF)
Male/female at least 18 years of age at the time the informed consent form (ICF) is signed
Probable or definite MMN according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) (EFNS/PNS) 2010 guidelines at screening confirmed by the MMN Confirmation Committee (MCC)
Receiving a stable IVIg regimen before screening
IVIg treatment dependency confirmation by the MMN Confirmation Committee (MCC)
Immunization with the first meningococcal vaccine and pneumococcal vaccine, and the single Haemophilus influenza type B vaccine must be performed at least 14 days before IMP administration at V1 according to local country-specific immunization schedules. A documented history of vaccination against Neisseria meningitides, Haemophilus influenza type B, and streptococcus pneumonia will be permitted
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria

Any coexisting condition which may interfere with the outcome assessments
Clinical signs or symptoms suggestive for neuropathies other than MMN such as motor neuron disease or other inflammatory neuropathies
Severe psychiatric disorder, history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the participant or could affect adherence with the trial protocol
Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection during the screening and/or IVIg monitoring period (IVMP)
Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of MMN or put the participant at undue risk (eg, SLE)
History of malignancy unless resolved by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following carcinomas will be eligible
Adequately treated basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Carcinoma in situ of the breast
Incidental histological finding of prostate cancer
Clinical evidence of other significant serious diseases, have had a recent major
surgery (including a splenectomy at any time), or who have any other condition
in the opinion of the investigator, that could confound the results of the
trial or put the participant at undue risk
Prior/concomitant therapy
Cyclophosphamide and/or rituximab and/or eculizumab and/or mycophenolate mofetil within 3 months prior to screening
Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP
Positive serum test at screening for an active viral infection with any of the
following conditions
Hepatitis B virus (HBV) that is indicative of an acute or chronic infection
Hepatitis C virus (HCV) based on HCV antibody assay
HIV based on test results that are associated with an AIDS-defining condition
Current or history of (ie, within 12 months of screening) alcohol, drug, or medication
abuse
Known hypersensitivity reaction to 1 of the components of the IMP or any of its excipients
Female participants with a positive serum or urine pregnancy test, lactating females, and those who intend to become pregnant during the trial or within 12 months after last dose of the IMP
ALT or AST ≥2 × upper limit of normal and total bilirubin ≥1.5 × upper limit of normal of the central laboratory reference range
An estimated glomerular filtration rate of ≤60 mL/min/1.73m2
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